Overview

The Institute for Agriculture and Trade Policy (IATP) appreciates this opportunity to comment on the "Notice." IATP last wrote to APHIS on June 17, 2017, concerning the Proposed Rule: Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms (Docket No. APHIS-2015-0057) ("Proposed Rule"). Following industry objections and to industry applause, USDA withdrew the Proposed Rule on November 7, 2017, leaving in place the current 20-year-old system for determining whether APHIS will regulate a specific genetic modification to a plant. Although USDA is apparently developing the programmatic EIS in advance of a new Proposed Rule, IATP urges USDA to draft the EIS to be consistent with the following step of the withdrawn Proposed Rule:

If APHIS determines that the GE plant is a noxious weed, it would endeavor to gauge the direct or indirect injury or damage it could cause to crops, livestock, poultry, or other interests of agriculture, irrigation, navigation, the natural resources of the United States, the public health, or the environment. APHIS would make the results of this evaluation publicly available and share both the evaluation and the information on which it is based with the Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA), as warranted. (Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules, p. 7011)

The determination of such "direct or indirect injury or damage" for the Proposed Rule is dictated by the requirements of the Plant Protection Act of 2000, specifically in the definition of "noxious weed," (7 USC 7702, para 10). APHIS must demonstrate that it has considered the scale and variety of "direct or indirect injury or damage" in finalizing a future Proposed Rule, if it is to comply with the statute.

APHIS has chosen to issue the Notice in advance of issuing a new Proposed Rule, whereas a draft EIS would normally be issued after a Proposed Rule, since the EIS is a decision-making tool to guide regulators on the impact of a proposed governmental action, such as a Proposed Rule. In anticipation of a new Proposed Rule that complies with the mandate to determine "direct or indirect injury or damage" resulting from GE plants and the agronomic practices required by the engineered traits of those plants, IATP advises APHIS to require of commercial applicants at least the following categories of information in the programmatic EIS:

• Outline the potential impacts of taking no action to regulate GE plants, per the "no action" alternative requirement of the EIS provision of the National Environmental Protection Act;
• Describe APHIS's understanding of the method/s used to identify non-target/off-target mutations of gene editing and characterize the risks associated with those mutations;
• Submit field trial information on gene flow outcrossing to open pollinated plants and to wild plants to verify that there is no "kill switch failure" in GE plant design;
• Submit field trial information and data on pesticide use and impacts from GE plants designed and patented to resist proprietary pesticides;
• Document the extent to which bioinformatic tools accurately predict the traits expressed from gene-edited plants and the use of whole genome sequencing by GE plant developers to analyze off-target or non-target mutations of those plants;
• Document agronomic and economic impacts of "superweed" resistance to GE plants under conventional crop land management practices;
• Describe actual or potential risks to plant health, of GE techniques, e.g. risk of disease susceptibility associated with specific gene deletions or gene silencing more generally;
• Assess potential decreases in biodiversity resulting from enhanced invasiveness of GE plants, as anticipated for stacked trait varieties in the 2007 APHIS EIS for Introduction of Genetically Engineered Organisms;
• Develop a programmatic EIS section for biosafety controls on gene drives for pest control generated from CRISPR Cas9 and other techniques.

The EIS docket should remain open and be periodically updated so that the public understands what studies and data APHIS is using to assess environmental impacts of GE plants.

IATP notes that in the Draft Programmatic Environmental Impact Statement: Introduction of Genetically Engineered Organisms of 2007, APHIS described a six month long public consultation process that included stakeholder meetings, surveys and written comments in response to a 2004 Notice for an EIS. Given the greater complexity and variety of application of genome editing techniques, IATP urges APHIS to at least offer as many opportunities for public input into the current draft EIS process. It is regrettable that APHIS did not respond affirmatively to a request to extend the deadline for the 30-day comment period to this Notice.

See the below PDF to continue reading IATP's letter to APHIS.